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Biologics Naming: WHO Final Plan, FDA Draft Guidance Incompatible

 
• By Sue Sutter

US regulator could try to harmonize its nonproprietary naming approach with World Health Organization's biological qualifier system or stick with its suffix-based proposal; while having different names across the globe for a single product is not ideal, it's also not an insurmountable problem, experts say.

With the World Health Organization having finalized a voluntary naming convention for biologics, the focus now turns to whether FDA will stick with its own proposed nomenclature approach or adopt the WHO model.

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